Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: Entecavir + Tenofovir; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410072

AI463-110

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

Enrollment: 669 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HbeAg]-positive or negative) disease
• Nucleoside- and nucleotide-naive
• Males or females ≥16 years of age (or minimum age of consent in a given country)
• Compensated liver function
• HBV DNA >1.72*10*5*IU/mL (approximately 10*6*copies/mL) for HbeAg-positive participants
• HBV DNA >1.72*10*4*IU/mL (approximately 10*5*copies/mL) for Hbe-Ag-negative participants
• Alanine aminotransferase level ≥*upper limit of normal (ULN) and ≤10*ULN

Exclusion criteria

• Evidence of decompensated cirrhosis
• Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
• Laboratory values out of protocol-specified range

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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669 participants in 2 patient groups

TDF 0.5 mg

Experimental group

Description:

TDF=tenofovir

Treatment:

Drug: Entecavir

ETV 0.5 mg +TDF 300 mg

Experimental group

Description:

ETV=entecavir; TDF=tenofovir

Treatment:

Drug: Entecavir + Tenofovir